Oct 17, 2017  |  Posted by: 

In 2011, FDA published a new guidance for the industry on Process Validation: General Principles and Practices. This guidance aligns process-validation activities with the product life-cycle concept which moves from the current 3 batch process to a 3-stage process requires significant changes with traditional validation process and approach. Traditional process validation is a paper-based inefficient and time-consuming process. Paper-based process vali...  
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Sep 28, 2017  |  Posted by: 

During the operational phase of Clean In Place (CIP) cycles companies rely in manual methods to determine the success of routine cleaning process. Some of these manual methods to determine the success of the routine cleaning cycles rely on performing very inefficient activities that are very costly and don’t have adequate cycle times. Some of these inefficient methods include the following examples:
Aug 30, 2017  |  Posted by: 

Validation is a global regulatory requirement in the life science industry. The purpose of validation is to establish evidence that systems and processes will consistently yield results that meet predetermined specifications. The goal of the validation process is to ensure that systems and processes work as intended and they meet user requirements. Validation regulatory requirements are driven by regulations such as FDA 21 CFR Part 11, EU Annex 11...  
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Aug 11, 2017  |  Posted by: 

Cleaning Validation is a critical regulatory requirement in the pharmaceutical, biotechnology and medical device industry. The purpose of cleaning validation is to establish evidence that the cleaning process will consistently yield results that meet predetermined specifications. The goal of the cleaning process is to remove the following:
  • All components from the previous product
  • Bioburden
  • Endotoxins
  • Deter...  
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Jul 26, 2017  |  Posted by: 

Leveraging the power of a Validation Lifecycle Management System (VLMS)

According to FDA 820.3(z) “Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” Ironically, the actual provision of objective evidence is subjective. Before we continue let’s call to mind the difference between subjective versus objective. A su...  
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Jun 29, 2017  |  Posted by: 

In the life science industry, all computer systems with GMP impact must be validated. Computer System Validation is intended to provide documented evidence that a computer system meets documented user requirements. User requirements need to be traceable to individual validation test using a traceability matrix. Unfortunately creating a traceability matrix manually is a very inefficient time consuming process that requires a lot of effort to maintain ...  
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May 25, 2017  |  Posted by: 

Leveraging Technology to Address the ALARP vs AFAP Challenge

It is a regulatory requirement for Medical Device companies to perform Risk Management and provide documented evidence to demonstrate compliance with regulation and a company’s own Quality Management System (i.e., Policy & Standard Operating Procedures). Expectations are stipulated in ISO 14971: Medical devices – Application of Read more »

May 05, 2017  |  Posted by: 

In the pharmaceutical, biotechnology and medical device industry equipment validation traditionally is a manual inefficient paper-based process that is plagued with bottle necks and high cost. The inefficiencies found in traditional equipment validation are related to manual activities such as routing documents for review, approval, printing, scanning, storing and archiving paper-based equipment validation documents. There is a significant amount of chal...  
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